ANDA 075747

SUN PHARM INDS LTD

FDA Drug Application

Application #075747

Documents

• Letter: 2004-06-01
• Letter: 2004-06-15

Application Sponsors

ANDA 075747

SUN PHARM INDS LTD

Marketing Status

• Discontinued: 001
• Discontinued: 002
• Discontinued: 003

Application Products

001	TABLET;ORAL	EQ 250MG BASE	0	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE
002	TABLET;ORAL	EQ 500MG BASE	0	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE
003	TABLET;ORAL	EQ 750MG BASE	0	CIPROFLOXACIN HYDROCHLORIDE	CIPROFLOXACIN HYDROCHLORIDE

FDA Submissions

	ORIG	1	AP	2004-06-09
LABELING; Labeling	SUPPL	9	AP	2008-06-18
LABELING; Labeling	SUPPL	10	AP	2008-12-04
LABELING; Labeling	SUPPL	11	AP	2009-07-22
LABELING; Labeling	SUPPL	12	AP	2013-11-18
LABELING; Labeling	SUPPL	13	AP	2013-11-18
LABELING; Labeling	SUPPL	14	AP	2013-11-18	STANDARD
LABELING; Labeling	SUPPL	15	AP	2013-11-18	STANDARD

Submissions Property Types

SUPPL	12	Null	7
SUPPL	13	Null	7
SUPPL	14	Null	24
SUPPL	15	Null	15

CDER Filings

SUN PHARM INDS LTD

cder:Array
(
    [0] => Array
        (
            [ApplNo] => 75747
            [companyName] => SUN PHARM INDS LTD
            [docInserts] => ["",""]
            [products] => [{"drugName":"CIPROFLOXACIN HYDROCHLORIDE","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 250MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIPROFLOXACIN HYDROCHLORIDE","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 500MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"},{"drugName":"CIPROFLOXACIN HYDROCHLORIDE","activeIngredients":"CIPROFLOXACIN HYDROCHLORIDE","strength":"EQ 750MG BASE","dosageForm":"TABLET;ORAL","marketingStatus":"Discontinued","te":"None","rld":"No","rs":"No"}]
            [labels] => 
            [originalApprovals] => [{"actionDate":"CIPROFLOXACIN HYDROCHLORIDE","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 250MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIPROFLOXACIN HYDROCHLORIDE","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 500MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"},{"actionDate":"CIPROFLOXACIN HYDROCHLORIDE","submission":"CIPROFLOXACIN HYDROCHLORIDE","actionType":"EQ 750MG BASE","submissionClassification":"TABLET;ORAL","reviewPriority":"Discontinued","inserts":"[]","notes":">No"}]
            [supplements] => 
            [actionDate] => 1969-12-31
        )

)